1. Field of the Invention
This invention relates, generally, to laparoscopic operations. More particularly, it relates to a morcellator for laparoscopic hysterectomies
2. Brief Description of the Prior Art
Laparoscopic surgery, a type of minimally invasive surgery, has increased over the past 10 years due to a dramatic decrease in post-operative patient recovery time, minimized risk of infections, less pain, and reduced scarring. Compared to traditional open cut surgery, laparoscopic surgery uses several small incisions from five (5) millimeters to fifteen (15) millimeters. These incisions are known as ports that hold hollow tubular trochars that are designed for the passing of instruments and devices. Typically, these ports are inserted through the subject or patient's abdominal wall into the peritoneal cavity to provide the surgeon with access to necessary organs. This complex system allows surgeons to perform surgeries with smaller incisions than traditional operations (ASCRS, 2008).
According to the U.S. Department of & Human Services, a hysterectomy (surgical removal of the uterus) is the second-most performed surgery (after cesarean section) on women in the United States with more than 600,000 of these operations performed each year. Of these, 42% were performed laparoscopically. It is estimated that one in three women in the U.S. has undergone a hysterectomy by the age of 60.
During hysterectomy laparoscopic surgeries, surgeons need clear visibility and range of device control at all times to avoid damaging nearby vital organs and blood vessels while reducing scars and pain for the patient. Depending on the severity and depth of the hysterectomy surgery, the operation can last from an hour to a few hours. This prolonged period of time combined with repetitive hand actions, may cause strain and fatigue (Gale Encyclopedia of Medicine, 2008). These problems lead to concerns in designing more ergonomic devices that may reduce the overall safety of the operation for physicians and patients.
Several devices that may be considered to be internal tissue removal devices exist for use in laparoscopic surgery. Oftentimes, surgeons use a device called a morcellator to extract large tissue masses through these incisions by cutting the tissue into smaller segments. The GYNECARE MORCELLEX tissue morcellator is one of the oldest single-patient-use devices. The device is inserted into the patient and allows tissue to be grasped with a standard grasping instrument extended through the device's central lumen. The tissue can be drawn up manually inside the device's central lumen into the inner stationary sheath as the exposed blade cuts the tissue. The greatest shortcoming of the GYNECARE MORCELLEX tissue morcellator is the uncertainty of the exposed blade that can cause damage to vital organs that surround the abdomen (Zullo, 2012).
Another possible prior art device, LINA XCISE disposable laparoscopic morcellator, consists of similar features, and therefore has the same flaws, as the GYNECARE MORCELLEX, but provides a cordless disposable morcellator, intended for tissue morcellation during laparoscopic gynecological procedures.
Another commercial device known as the MYOSURE Tissue Removal System is a device having a distal end with a side window that rotates and reciprocates so as to cut tissue. Simultaneously, the cut tissue is sucked out of the body through the body/sheath of the device. The device has a diameter of about 6.5 mm, so although a smaller incision site is necessary, the targeted tissue must be broken down into significantly smaller portions for suction out of the body. Additionally, this device runs across similar flaws as previously described, such as remnants remaining in the body (particularly here where tissue must be broken down so much).
U.S. Pat. No. 7,510,563 to Cassidy et al. and U.S. Pat. No. 7,226,459 to Cassidy et al. have a similar cutting window with a cutting blade exposed when the window is opened. The blade is rotated, thereby cutting tissue and bringing the cut tissue into the cutting window for aspiration. However, to be cut, the tissue within the cutting window must catch on a sharp hook disposed on the opposite side of the cutting window as the blade. Then the blade slices the tissue and rotates to advance the tissue out of the body through a suction mechanism. Thus, the sharp hook and blade are exposed to peripheral tissue, and the cutting window significantly limits the amount of tissue that can be cut in an efficient manner.
Another example is U.S. Pat. No. 6,039,748 to Savage et al. This device utilizes a circular rotating blade to cut tissue while a grasping device is inserted through the proximal end of a sheath to the distal end of the sheath to manually grasp and pull tissue while the cutting blade cuts tissue. Savage is provides a device designed to fit inside the lumen of the morcellator, allowing the grasper to be inserted and removed while maintaining positive pressure within the abdomen of the patient. As the tissue is pulled proximally back through the lumen of the morcellator, the cutting blade cuts the tissue. However, this device requires excessive manual effort from the surgical team, it would be easy for a portion of the tissue to become entirely cut off from the remaining tissue and be improperly left within the subject.
U.S. Pat. No. 5,562,694 to Sauer et al, teaches a device designed with cutting teeth that reciprocate back and forth in a sawing motion to cut masses. The top of this device has cooperative jaw members that open and close in a jaw-like manner in order to grasp tissue. When the tissue is grasped, the saw blade is activated and cuts through the tissue in an effectuating remote reciprocal movement, as the jaw closes to encapsulate the mass. The device is designed to operate with a manual grasper inserted through the proximal end that extends from the sheath when the jaw is open to grasp and pull tissue within the device for cutting. However, the device requires manual manipulation of the grasper to remove tissue from the body. Additionally, the methodology of cutting, using a sawing motion, is inefficient and exposes surrounding tissue to being improperly cut.
U.S. Pat. No. 5,443,472 to Li discloses a morcellation system primarily consisting of two main mechanisms. One mechanism acts as a capture device to capture a tissue mass while the other mechanism acts as a morcellator to cut and remove tissue from the body. The mass is captured in a net-like, tissue containment structure that can articulate at an angle while the cutting device is positioned inside. The cutting device has a blade opening, and the net-like structure is used to squeeze the mass into the opening created by the blade opening. From this point, the surgeon squeezes the handle to close the blade, which cuts the tissue, and the action of opening the blade causes the piece of tissue that was cut to move proximally through the device. Within the device, barbs exist that allow only one way proximal movement through the tube of the device. As each additional piece of tissue is cut by the device, the newest piece of tissue within the tube pushes the last piece of tissue up towards the proximal end. However, the entirety of the mechanism of this device is manual and in particular relies on the grip of the surgeon's hand to actuate the cutting blade. The device itself provides several points of inefficiency and an excess of energy consumption required from the surgical team.
U.S. Pat. No. 5,520,634 to Fox et al. relates to a morcellator that is structured with a rotatable cutting head (e.g., a blade) and a motor that communicates the rotation of the cutting head, along with suction through the cutting head to aspirate the masses that are cut. The cutting head is “relatively retractable” but extends out of the sheath, thereby exposing the blade to other non-targeted tissue within the body. Further, the device is designed to go through an abdominal port and thus is limited to the size of the port.
U.S. Pat. No. 5,569,284 to Young et al. teaches a morcellator that includes a tabular portion with an elongated auger rotatably positioned within its bore. An aperture near the distal end of the tubular portion permits access for body tissue to contact the auger. However, the device is limited to fifteen (15) mm and is inserted in an abdominal port to come in contact with the tissue. Additionally, the auger has a cover flap over the aperture, where the cover flap that opens to allow the auger to contact the tissue for cutting and transporting out of the body. The cover flap opens at an angle and thus the amount of tissue that can be efficiently cut is quite limited.
U.S. Pat. No. 5,215,521 to Cochran et al. discloses a device that is designed to contain a bag within a sheath until the bag is deployed within a body to enclose and hold a mass within the body. The bag holds the mass in place to allow the surgeon to use a morcellator to break down the mass until the bag containing the morcellized mass can be removed through the device sheath and port. This device is focused on holding the material and attempting to reduce the amount of tissue that escapes when being morcellated. However, it appears that the organ must physically be placed into the bag prior to morcellation. This creates a larger burden on the surgical team. Additionally, there are many moving parts and complexities that may result in a malfunction of the device, particularly when deploying the bag within a body.
U.S. Pat. No. 6,468,228 to Topel et al. relates to a morcellator that includes a helical coil inserted through the hollow sheath and extends from the distal cutting end of sheath to embed into a tissue mass and affix itself in the mass. The helical coil then is pulled back with the tissue mass, and the cutting end of the sheath cores or morcellates the tissue mass until completion. This device suffers many of the drawbacks previously explained through traditional morcellation techniques. In particular, the tissue must be manually removed, and remnant tissue may remain within the body improperly.
U.S. Pat. No. 8,282,572 to Bilsbury teaches a bag deployment device that uses a sheath to guide and insert the bag into the body. The device uses a flexible metal to push and expand the bag/funnel once outside of the sheath. The bag is intended to capture the tissue within the body and fit within the sheath for removal outside of the body. The drawbacks of this device are that the tissue masses must be small enough for removal from the body, as the device does not morcellate the tissue, rather simply attempting to transport whole tissue outside of the body.
U.S. Pat. No. 5,591,187 to Dekel discloses a device that includes a hollow cylindrical sheath with a rotatable auger disposed therein for rotational cutting. The distal end of the auger includes a cutting blade outside of the sheath. Additionally, the distal end of the auger has an opening that receives a corkscrew-like structure that extends furthest distally from the auger and is used to engage the tissue mass to be cut. Thus, the corkscrew-like structure engages the tissue mass and positions the tissue mass for cutting by the serrated blade. Then the tissue is drawn into the sheath by the auger, which is being manually rotated by the user. Major drawbacks of this device include peripheral or extraneous tissue being exposed to both the cutting blade and the corkscrew-like structure. This may be particularly true when there are smaller pieces of tissue that need to be removed, and the corkscrew-like structure is incapable of engaging it. Additionally, the tissue must be extracted manually, and as such, small pieces of tissue may be left in the body. The device provides an inefficient and dangerous manner of removing tissue from a body.
The devices currently used for laparoscopic surgeries lead to problems that are evident during an operation. These problems include lack of proper cutting efficiency, safety concerns, and excessive scarring. As indicated, a wide variety of different morcellation devices have been used in attempts to facilitate tissue removal, but there has been no growth for an effective cutting design.
Accordingly, what is needed is an improved streamlined morcellation cutting device for laparoscopic surgeries that is safe and effective during and after surgery. However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the field of this invention how the shortcomings of the prior art could be overcome.
All referenced publications are incorporated herein by reference in their entirety. Furthermore, where a definition or use of a term in a reference, which is incorporated by reference herein, is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, Applicants in no way disclaim these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein.
The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.
In this specification, where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.